Measure the time required for blood flow to return to baseline after cold exposure

Secondary Outcome Measures:

Measure the time required for skin temperature to return to baseline after cold exposure

Prevention or reduction of symptoms following cold exposure.

Estimated Enrollment:

15

Study Start Date:

July 2006

Study Completion Date:

July 2006

Detailed Description:

The Purpose of this clinical study is to determine, in a controlled fashion, the response to two dosage strengths of a topical gel formulation of Nitroglycerin, MQX-503, in the determination of changes in finger blood flow and skin temperature in the fingers of patients with moderate to severe primary Raynaud's phenomenon and with Raynaud's phenomenon secondary to autoimmune diseases, such as scleroderma. The dosage strength response in the treatment of the symptoms (pain, tingling, numbness) will also be monitored.

Eligibility

Ages Eligible for Study:

18 Years to 75 Years

Genders Eligible for Study:

Both

Criteria

Inclusion Criteria:

Outpatients, 18 to 75 years

Clinical Diagnosis of Raynaud's, or observed event by study physician, or symptoms with reduced blood flow as meausred using laser doppler equipment

Agree to have test gels applied to finger

Discontinue current vasodialator therapeis for Raynaud's treatment

Four weeks from last clinical trial participation

Agree not to use any other investigational medications or therapies to treat Raynaud's and its symptoms while participating in this study including other dosages or forms of nitroglycerin, isosorbide dinitrate, fenoldopam mesylate, milrinone lactate, nifedipine, diltiazem, felodipine, nimodipine, nisoldipine, and verapamil

Negative pregnancy test for women prior to study start and agree to use effective contraception throughout

Must be able to give written informed consent and comply with all study requirements

Exclusion Criteria:

Concurrent use of any nitrate medication or medications known to interact with Nitroglycerin such as sildenafil, and other treatments for erectile dysfunction

Patients who have a known allergy to Nitroglycerin or common topical gel ingredients

Patients with a history of migraine, cluster or vascular headaches, or those who suffer from chronic pain

Patients with a history of an unstable medical problem or any current condition that would interfere in participation in the study

Patients unable to complete pain assessment instructions

Patients who in the last three months have had a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension or uncontrolled hypertension

Patients who have participated in another investigational drug study within four weeks of the first study treatment

Patients with out of range laboratory screening values

Patients who have had major abdominal, thoracic or vascular surgery within six months of the first study treatment

Patients with open lesions or skin conditions where gel is to be applied

Pregnant or nursing women

Women who will not agree to comply with contraceptive requirements

Patients with a history of poor compliance, poor cooperation or unreliability

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378521